Androgen Receptor Modulator And Uses Thereof

Abstract

Described herein is the androgen receptor modulator of formula (I)in the treatment of prostate cancer in combination with other therapeutic options and in the treatment of diseases or conditions that are amenable to treatment with the androgen receptor modulator, as well as pharmaceutical compositions and medicaments that include such compound.

What is claimed is: 
     
         1 . A method of treating metastatic castration-resistant prostate cancer, non-metastatic castration-resistant prostate cancer, metastatic castration-sensitive prostate cancer, non-metastatic castration-sensitive prostate cancer, or high-risk localized prostate cancer in a male human patient comprising orally administering the compound of Formula (I) 
       
         
           
           
               
               
           
         
       
       to a human male patient in need of such treatment at a dose of about 30 mg per day to about 480 mg per day, in combination with abiraterone acetate and prednisone. 
     
     
         2 . The method according to  claim 1 , wherein the abiraterone acetate is administered at a dose in a range of from about 500 mg per day to about 1000 mg per day. 
     
     
         3 . The method according to  claim 1 , wherein the prednisone is administered at a dose of about 5 mg twice per day. 
     
     
         4 . The method according to  claim 1 , wherein the compound of Formula (I), 
       
         
           
           
               
               
           
         
       
       is administered at a dose of about 240 mg per day. 
     
     
         5 . The method according to  claim 1 , wherein the treating results in a decrease in the patient's prostate-specific antigen levels of at least 50% from baseline after 3 months of the compound of Formula (I), 
       
         
           
           
               
               
           
         
       
       on a continuous daily dosing schedule. 
     
     
         6 . The method according to  claim 1 , wherein the patient was previously administered bicalutamide, flutamide or nilutamide. 
     
     
         7 . The method according to  claim 1 , wherein the compound of Formula (I) 
       
         
           
           
               
               
           
         
       
       and abiraterone acetate and prednisone are administered on a continuous daily dosing schedule. 
     
     
         8 . The method according to  claim 1 , wherein the compound of Formula (I) 
       
         
           
           
               
               
           
         
       
       and abiraterone acetate and prednisone are administered at the same time. 
     
     
         9 . The method according to  claim 1 , wherein the compound of Formula (I) 
       
         
           
           
               
               
           
         
       
       and abiraterone acetate and prednisone are administered at different times. 
     
     
         10 . The method according to  claim 1 , wherein the compound of Formula (I) 
       
         
           
           
               
               
           
         
       
       and abiraterone acetate and prednisone are administered by the same route of administration. 
     
     
         11 . The method according to  claim 1 , further comprising administering a therapeutically effective amount of leuprolide acetate, goserelin acetate, degarelix, ozarelix, ABT-620 (elagolix), TAK-385 (relugolix), EP-100 or KLH-2109. 
     
     
         12 . The method according to  claim 1 , wherein the compound of formula (I) 
       
         
           
           
               
               
           
         
       
       abiraterone acetate and prednisone are administered in further combination with leuprolide acetate. 
     
     
         13 . The method according to  claim 12 , wherein the leuprolide acetate is administered as a depot injection at a dose of 7.5 mg every 4 weeks, or 22.5 mg every 3 months, or 30 mg every 4 months, or 45 mg every 6 months. 
     
     
         14 . The method according to  claim 1 , wherein the compound of Formula (I) 
       
         
           
           
               
               
           
         
       
       abiraterone acetate and prednisone are administered in further combination with goserelin acetate. 
     
     
         15 . The method according to  claim 14 , wherein the goserelin acetate is administered as a subcutaneous implant at a dose of 3.6 mg every 4 weeks or 10.8 mg every 12 weeks. 
     
     
         16 . The method according to  claim 1 , wherein the compound of Formula (I) 
       
         
           
           
               
               
           
         
       
       abiraterone acetate and prednisone are administered in further combination with degarelix. 
     
     
         17 . The method according to  claim 16 , wherein the degarelix it is administered as a subcutaneous injection at a dose of about 240 mg followed by about 80 mg administered every 4 weeks. 
     
     
         18 . The method according to  claim 1 , wherein the prostate cancer is metastatic castration-resistant prostate cancer. 
     
     
         19 . The method according to  claim 1 , wherein the prostate cancer is non-metastatic castration-resistant prostate cancer. 
     
     
         20 . The method according to  claim 1 , wherein the prostate cancer is metastatic castration-sensitive prostate cancer. 
     
     
         21 . The method according to  claim 1 , wherein the prostate cancer is non-metastatic castration-sensitive prostate cancer. 
     
     
         22 . The method according to  claim 1 , wherein the prostate cancer is high-risk localized prostate cancer.